NCT03335956 - CORT125281 Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 21, 2017

Primary Completion Date

May 31, 2018

Study Completion Date

June 25, 2018

Conditions

Healthy

Interventions

DRUG

CORT125281, 40mg, fasted

CORT125281 is supplied as capsules for oral dosing

DRUG

Prednisone 25mg, fasted

"Challenge Agent, Dose and Route of Administration:~Standard release 25 mg tablets, orally administered"

DRUG

Placebo oral capsule, fasted

"Reference Therapy, Dose and Route of Administration:~Placebo capsule, orally administered"

DRUG

Pioglitazone 15mg Tablet

"Probe Substrate, Dose and Route of Administration:~15 Mg tablet, orally administered"

DRUG

Placebo oral capsule, fed

"Reference Therapy, Dose and Route of Administration:~Placebo capsule, orally administered"

DRUG

Prednisone 25mg, fed

"Challenge Agent, Dose and Route of Administration:~Standard release 25 mg tablets, orally administered"

DRUG

CORT125281, 120mg, fasted

CORT125281 is supplied as capsules for oral dosing

DRUG

CORT125281, 360mg, fasted

CORT125281 is supplied as capsules for oral dosing

DRUG

CORT125281, 720mg, fasted

CORT125281 is supplied as capsules for oral dosing

DRUG

CORT125281, 360mg, fed

CORT125281 is supplied as capsules for oral dosing

DRUG

CORT125281, 360mg

CORT125281 is supplied as capsules for oral dosing twice, 12 hours apart, fasted (morning) and after evening meal

DRUG

CORT125281, 120mg

CORT125281 is supplied as capsules for oral dosing once daily

DRUG

CORT125281, 180mg

CORT125281 is supplied as capsules for oral dosing twice daily

DRUG

CORT125281, 240mg

CORT125281 is supplied as capsules for oral dosing twice daily

DRUG

CORT125281, 360mg

CORT125281 is supplied as capsules for oral dosing once daily

DRUG

Placebo oral capsule

"Reference Therapy, Dose and Route of Administration:~Placebo capsule, orally administered twice, 12 hours apart, fasted (morning) and after evening meal"

DRUG

Placebo oral capsule

"Reference Therapy, Dose and Route of Administration:~Placebo capsule, orally administered, twice daily"

DRUG

Placebo oral capsule

"Reference Therapy, Dose and Route of Administration:~Placebo capsule, orally administered, once daily"

Trial Locations (1)

Unknown

Hammersmith Medicines Research, London